Adverse events and inefficacy of PCSK9 Inhibition with evolocumab or alirocumab in hypercholesteraemic patients

Adverse events and inefficacy of PCSK9 Inhibition with evolocumab or alirocumab in hypercholesteraemic patients - AKITA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55799

Enrollment

Registered

2018-10-15

Start date

2018-11-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients - On therapy or discontinued therapy with alirocumab 75mg 1x/2weeks or 150mg 1x/2weeks, or with evolocumab 140mg 1x/2weeks. - Failure of PCSK9 inhibitor therapy, due to adverse effects leading to discontinuation of the drug OR - Failure of PCSK9 inhibitor therapy, due to less than 30 percent reduction in LDL-C observed by the referring physician - >18 years of age, Controls: - On therapy with alirocumab or with evolocumab - On therapy with alirocumab or with evolocumab - No adverse effects leading to discontinuation of the drug - LDL-C reduction above 30 percent., - >18 years of age.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The main study parameters are differences in clinical parameters (e.g., patient anthropometrics between patients and controls, mutations in the PCSK9 gene possibly interfering with PCSK9 inhibitor therapy, variants in other lipid metabolism or PCSK9 related genes, gene expression, (semi)quantification of proteins (PCSK9 protein, other proteins involved in lipid metabolism, proteomics), (semi-)quantification of metabolites (e.g. lipids/fatty acids).	—

Measure

Time frame

The main study parameters are differences in clinical parameters (e.g., patient anthropometrics between patients and controls, mutations in the PCSK9 gene possibly interfering with PCSK9 inhibitor therapy, variants in other lipid metabolism or PCSK9 related genes, gene expression, (semi)quantification of proteins (PCSK9 protein, other proteins involved in lipid metabolism, proteomics), (semi-)quantification of metabolites (e.g. lipids/fatty acids).

—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results